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Telemedicine and Anger Management Groups With PTSD Veterans in the Hawaiian Islands

6 avril 2015 mis à jour par: US Department of Veterans Affairs

Telemedicine and Anger Management Groups for PTSD Veterans in the Hawaiian Islands

Telemedicine has the potential to profoundly influence the delivery of specialized care to the remote veteran population suffering with PTSD. Preliminary research supports telemedicine technology as a possible solution to improve access to mental health services for veterans with PTSD. The proposed research is a treatment-outcome study that will assess the clinical efficacy of conducting an Anger Management Therapy (AMT) group treatment intervention using a videoteleconferencing (VTC) modality as compared to the traditional in-person modality with veterans who have PTSD and reside in remote locations on the Hawaiian Islands. AMT is a manual-guided cognitive-behavioral, skill based group intervention that has been used nationwide in VA substance abuse programs and most recently has been adopted by many VA PTSD Clinical Teams to treat anger-related to the sequelae of PTSD.

Aperçu de l'étude

Statut

Complété

Description détaillée

Background: Posttraumatic stress disorder (PTSD) is a prevalent problem among military troops. Recovery from combat-related PTSD is often complicated by problems with anger. Veterans with difficulties managing PTSD-related anger may be particularly likely to live in remote geographical regions where access to specialized mental health care is often limited. Telemental health (TMH) has been touted as a potential means of increasing access to care in rural or remote areas. Objectives: This study compared the effectiveness of group Anger Management Therapy (AMT) delivered via videoteleconferencing (VTC) and in-person delivery in a sample of rural combat veterans with PTSD. The long-range objective of this project was to develop an empirically sound TMH protocol that will facilitate the extension of manual guided clinical services to remote sites via VTC. We hypothesized that providing a manualized group therapy intervention via VTC would result in similar reductions in anger symptoms as obtained from traditional in-person care. Further, we hypothesized that key process indicators (i.e., attrition, adherence, satisfaction, and therapeutic alliance) would not be significantly different between the VTC and in-person conditions. The specific objectives of this project were to: a) determine if group AMT delivered via VTC is as effective as the same intervention delivered in-person on clinical outcomes measuring reductions in anger symptoms and b) determine if group AMT delivered via VTC is as effective as the same intervention delivered in-person on group process outcomes. Methods: A randomized controlled non-inferiority trial of 125 male veterans with PTSD and anger difficulties was conducted at three Department of Veterans Affairs' outpatient clinics. Participants were randomly assigned to receive AMT delivered in a group setting with the therapist either in-person (N= 64) or via VTC (N= 61). Participants were assessed at baseline, mid-treatment, post-treatment, and 3 and 6-months post-treatment. The primary clinical outcome was reduction of anger difficulties, as measured by the Anger Expression and Trait Anger subscales of the State-Trait Anger Expression Inventory (STAXI-2) and the Novaco Anger Total Scale (NAS). Process variables were measured to assess the feasibility of AMT delivered via VTC. SAS MEANS procedure was used to calculate means and standard deviations for change from baseline at subsequent assessment points for both intent-to-treat and per-protocol analysis.

Type d'étude

Interventionnel

Inscription (Réel)

125

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Hawaii
      • Honolulu, Hawaii, États-Unis, 96819-1522
        • VA Pacific Islands Health Care System, Honolulu, HI

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Homme

La description

Inclusion Criteria:

  • male
  • PTSD diagnosis
  • anger level at Staxi Trait Score=22 or higher
  • stable medication regime

Exclusion Criteria:

  • current substance dependence
  • current psychosis
  • suicidal
  • homicidal
  • cognitive impairment

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Videoteleconferencing AMT

The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.

Behavioral: 12 sessions Anger Management Therapy. Anger Management Treatment (AMT), a 12-session manual-driven cognitive-behavioral intervention developed and found efficacious for anger management treatment with substance abuse veterans and has been applied to the PTSD population. AMT is highly structured with both psychoeducational and psychotherapy components. AMT is aimed at reducing anger affect and aggression through increasing anger management skills.

Anger Management Treatment (AMT), a 12-session manual-driven cognitive-behavioral intervention developed and found efficacious for anger management treatment with substance abuse veterans and has been applied to the PTSD population. AMT is highly structured with both psychoeducational and psychotherapy components. AMT is aimed at reducing anger affect and aggression through increasing anger management skills.
Autres noms:
  • AMT
Comparateur actif: Face to Face AMT

The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality.

Behavioral: 12 sessions Anger Management Therapy. Anger Management Treatment (AMT), a 12-session manual-driven cognitive-behavioral intervention developed and found efficacious for anger management treatment with substance abuse veterans and has been applied to the PTSD population. AMT is highly structured with both psychoeducational and psychotherapy components. AMT is aimed at reducing anger affect and aggression through increasing anger management skills.

Anger Management Treatment (AMT), a 12-session manual-driven cognitive-behavioral intervention developed and found efficacious for anger management treatment with substance abuse veterans and has been applied to the PTSD population. AMT is highly structured with both psychoeducational and psychotherapy components. AMT is aimed at reducing anger affect and aggression through increasing anger management skills.
Autres noms:
  • AMT

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
State-Trait Anger Inventory (STAXI-2) Anger Expression Index
Délai: Baseline
Anger expression was measured using the STAXI-2's 32-item Anger Expression Index (range 0 - 96). The STAXI-2 subscale have robust psychometric properties including high internal consistency, external validity, and construct validity. The Anger Expression Index provides a general measure of anger expression; assessing one's experience, expression and efforts to control anger. Higher scores indicate more problematic levels of anger and its expression.
Baseline
State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale
Délai: Post-treatment (2 weeks following last treatment session)
Anger expression was measured using the STAXI-2's 32-item Anger Expression Index (range 0 - 96). The STAXI-2 subscale have robust psychometric properties including high internal consistency, external validity, and construct validity. The Anger Expression Index provides a general measure of anger expression; assessing one's experience, expression and efforts to control anger. Higher scores indicate more problematic levels of anger and its expression.
Post-treatment (2 weeks following last treatment session)
State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale
Délai: 3-month Follow Up
Anger expression was measured using the STAXI-2's 32-item Anger Expression Index (range 0 - 96). The STAXI-2 subscale have robust psychometric properties including high internal consistency, external validity, and construct validity. The Anger Expression Index provides a general measure of anger expression; assessing one's experience, expression and efforts to control anger. Higher scores indicate more problematic levels of anger and its expression.
3-month Follow Up
State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale
Délai: 6-month Follow Up
Anger expression was measured using the STAXI-2's 32-item Anger Expression Index (range 0 - 96). The STAXI-2 subscale have robust psychometric properties including high internal consistency, external validity, and construct validity. The Anger Expression Index provides a general measure of anger expression; assessing one's experience, expression and efforts to control anger. Higher scores indicate more problematic levels of anger and its expression.
6-month Follow Up
Novaco Anger Scale (NAS)
Délai: Baseline
Anger disposition was assessed using the total scale score from the Novaco Anger Scale. This 60-item measure (range = 60 - 180) is a well validated self-report instrument designed to measure cognitive, arousal, and behavioral aspects of anger in both clinical and non-patient populations. Higher scores indicate more anger-related symptoms.
Baseline
Novaco Anger Scale (NAS)
Délai: Post-treatment (2 weeks following last treatment session)
Anger disposition was assessed using the total scale score from the Novaco Anger Scale. This 60-item measure (range = 60 - 180) is a well validated self-report instrument designed to measure cognitive, arousal, and behavioral aspects of anger in both clinical and non-patient populations. Higher scores indicate more anger-related symptoms.
Post-treatment (2 weeks following last treatment session)
Novaco Anger Scale (NAS)
Délai: 3-Month Follow Up
Anger disposition was assessed using the total scale score from the Novaco Anger Scale. This 60-item measure (range = 60 - 180) is a well validated self-report instrument designed to measure cognitive, arousal, and behavioral aspects of anger in both clinical and non-patient populations. Higher scores indicate more anger-related symptoms.
3-Month Follow Up
Novaco Anger Scale (NAS)
Délai: 6-Month Follow Up
Anger disposition was assessed using the total scale score from the Novaco Anger Scale. This 60-item measure (range = 60 - 180) is a well validated self-report instrument designed to measure cognitive, arousal, and behavioral aspects of anger in both clinical and non-patient populations. Higher scores indicate more anger-related symptoms.
6-Month Follow Up

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
PTSD Checklist-military Version (PCL-M)
Délai: Baseline
Self report that measures severity of PTSD symptoms. The PCL-M measures the 17 cardinal symptoms of PTSD as described in the DSM-IV-TR. The scale ranges from 0 - 85 with higher scores indicating worse PTSD symptoms. PTSD symptoms were measured at baseline and post-treatment only.
Baseline
PTSD Checklist-military Version (PCL-M)
Délai: Post-treatment (2 weeks following last treatment session)
Self report that measures severity of PTSD symptoms. The PCL-M measures the 17 cardinal symptoms of PTSD as described in the DSM-IV-TR. The scale ranges from 0 - 85 with higher scores indicating worse PTSD symptoms. PTSD symptoms were measured at baseline and post-treatment only.
Post-treatment (2 weeks following last treatment session)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 août 2005

Achèvement primaire (Réel)

1 octobre 2008

Achèvement de l'étude (Réel)

1 décembre 2009

Dates d'inscription aux études

Première soumission

18 juillet 2005

Première soumission répondant aux critères de contrôle qualité

18 juillet 2005

Première publication (Estimation)

21 juillet 2005

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

28 avril 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 avril 2015

Dernière vérification

1 août 2014

Plus d'information

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur 12 sessions Anger Management Therapy.

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